RightFit
RecruitingNot applicable

Alleviant ALLAY-HFrEF Study

Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and benefits of the Alleviant ALV1 System for people with heart failure whose heart pumps less blood than normal. The system creates a small opening between the heart’s upper chambers through a tube placed in a blood vessel. The study compares this treatment with a pretend procedure.

Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The heart’s main pumping chamber pumps out 40% or less of its blood with each beat.
  • Heart failure causes symptoms with activity, or at rest while you are still able to walk around (NYHA class II, III, or ambulatory IV).
  • You are on a stable plan of recommended heart failure medicines at the highest doses you can tolerate.

Who can't join

  • Advanced heart failure.
  • Expected to live less than 12 months.
  • Signs that the right side of the heart is not working well.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * LVEF ≤ 40% * NYHA class II, III or ambulatory IV HF * Receiving optimal, maximally tolerated, stable GDMT Exclusion Criteria: * Advanced heart failure * Life-expectancy \< 12 months * Evidence of right heart dysfunction

Study sites (40)

CA

FL

GA

  • Atlanta VA Health Care System · Decatur, GA 30032Gautum Kumar, MD · Principal investigatorMore trials in Decatur

IL

  • Midwest Cardiovascular Institute · Naperville, IL 60540Stanislaw Skaluba, MD · Principal investigatorMore trials in Naperville

LA

  • Cardiovascular Institute of the South · Houma, LA 70360Peter Fail, MD · Principal investigatorMore trials in Houma
  • University Medical Center New Orleans · New Orleans, LA 70112Frank Smart, MD · Principal investigatorMore trials in New Orleans

MA

  • Tufts Medical Center · Boston, MA 02111Jeong Hwan Kim, MD · Principal investigatorMore trials in Boston
  • Brigham and Women's Hospital · Boston, MA 02115Pinak Shah, MD · Principal investigatorMore trials in Boston
  • Boston Medical Center · Boston, MA 02118Nir Ayalon, MD · Principal investigatorMore trials in Boston

MN

  • Minneapolis Heart Institute Foundation · Minneapolis, MN 55407Peter Eckman, MD · Principal investigatorMore trials in Minneapolis

MO

  • Washington University - St Louis · St Louis, MO 63110Ali Javaheri, MD, PhD · Principal investigatorMore trials in St Louis

NC

  • Mission Hospital · Asheville, NC 28801Vinay Thohan, MD · Principal investigatorMore trials in Asheville
  • Duke University Hospital · Durham, NC 27705Robert Mentz, MD, FACC, FAHA, HFSA · Principal investigatorMore trials in Durham
  • NC Heart and Vascular Research · Raleigh, NC 27607Elizabeth Volz, MD · Principal investigatorMore trials in Raleigh

NJ

NV

NY

  • Stony Brook Medicine · New York, NY 11794Ahmad Alkhalil, MD · Principal investigatorMore trials in New York
  • Rochester General Hospital · Rochester, NY 14621Elizabeth Lee, MD · Principal investigatorMore trials in Rochester
  • University of Rochester Medical Center · Rochester, NY 14642Denizhan Ozdemir, MD, PhD · Principal investigatorMore trials in Rochester

OH

PA

  • Pinnacle Health Cardiovascular Institute · Harrisburg, PA 17101Hemal Gada, MD · Principal investigatorMore trials in Harrisburg

SC

  • Roper St. Francis Healthcare · Charleston, SC 29414Matthew O'Steen, MD · Principal investigatorMore trials in Charleston
  • Medical University of South Carolina · Charleston, SC 29425Brian Houston, MD · Principal investigatorMore trials in Charleston

SD

TN

  • Tennova Healthcare - Turkey Creek Medical Center · Knoxville, TN 37934Malcolm Foster · Principal investigatorMore trials in Knoxville

TX

VA